Differentiating Type 1 and Type 2 Diabetes Mellitus
An estimated 422 million people across the world are living with diabetes1. Diabetes Mellitus (DM) encompasses a collection of chronic diseases characterised by absent or ineffective insulin activity. Insulin is a hormone produced by the pancreas responsible for a host of essential physiological processes related to glucose metabolism and protein synthesis.
There are two main forms of DM, named type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) which result from different mechanisms and more importantly, require different therapeutic approaches. It is estimated that up to 40% of those diagnosed with T2DM after the age of 30 may have been misdiagnosed2. This misdiagnosis of T1DM as T2DM will result in poor glycaemic control, frequent healthcare contact for increased treatment, inappropriate insulin regimes and risk of life-threatening ketoacidosis.
In this article, we’ll look at the similarities and differences between these two forms of DM and investigate the mechanisms by which these common diseases arise.
The normal insulin signalling pathway, shown below, is responsible for the processing and transport of glucose in the body. Briefly, insulin binds to the insulin receptor and activates PI3K and, subsequently, serine-threonine kinase (AKT). AKT is responsible for the phosphorylation of glycogen synthase kinase 3-β (GSK-3β), inhibiting its activity and promoting the synthesis of glycogen leading to a reduction in blood glucose concentration. Failing to inhibit GSK-3β will result in hyperglycaemia and eventually T2DM.
Type 1 Diabetes Mellitus
T1DM is most commonly diagnosed at a young age. This form of DM is the result of an autoimmune reaction to proteins produced by the pancreas which results in a lack of insulin secretion. The antibodies responsible for this autoimmunity are detailed in the table below:
A key factor in T1DM pathogenesis is changes in the T cell-mediated immunoregulation, notably in the CD4+ T cell compartment. The activation of the CD4+ T cells is responsible for inflammation of the pancreatic cells which produce insulin, known as insulitis.
Changes in the expression of IL-1 and TNFα cause structural alterations in pancreatic β-cells which result in the suppression of insulin secretion. This insulin deficiency has subsequent effects on glucose metabolism and protein synthesis.
T1DM causes an increase in hepatic glucose levels when gluconeogenesis converts glycogen to glucose. A lack of insulin means the subsequent hepatic uptake of this glucose does not occur.
Insulin is also responsible for regulating the synthesis of many proteins. This regulation can be positive or negative but ultimately results in an increase in protein synthesis and a decrease in protein degradation. Therefore, when hypoinsulinemia occurs, decreasing insulin concentration in the blood, protein catabolism is increased leading to increased plasma amino acid concentration.
Type 2 Diabetes Mellitus
The pathogenesis of T2DM, detailed in the diagram below, is multi-factorial. It arises from a combination of genetic and environmental factors which affect insulin activity.
In T2DM, the regulatory mechanisms related to glucose metabolism fail resulting in impaired insulin activity or insulin resistance.
Mutations in genes involved in insulin production can cause the secretion of abnormal insulin molecules, known as insulinopathies. Insulinopathies are unable to effectively metabolise glucose which results in the accumulation of this sugar. Additionally, obesity is considered to be a causal factor in the development of T2DM.
Unlike those with T1DM, patients with T2DM can maintain circulating insulin levels. T2DM is characterised by glucose intolerance, impaired glucose tolerance, diabetes with minimal fasting hyperglycaemia, and DM in association with overt fasting hyperglycaemia.
Individuals with impaired glucose tolerance have hyperglycaemia despite preserving high levels of plasma insulin. These levels of insulin decline from impaired glucose tolerance to DM. It is insulin resistance is considered the primary cause of T2DM.
The misdiagnosis of these types of DM is common, due to similar symptoms. The simplest differentiating factor is when these symptoms manifest. T1DM is an autoimmune disorder and therefore, symptoms generally occur much earlier in one’s life. T2DM is typically diagnosed in later life. The common symptoms of DM are:
- Frequent urination, particularly throughout the night.
- Polydipsia (excessive thirst)
- Polyphagia (excessive hunger)
- Sudden weight loss
- Genital itching or thrush
- Blurred vision
The misdiagnosis of T2DM as T1DM results in unnecessary initial insulin therapy, higher drug and monitoring costs and often, an increase in the number and severity of symptoms. Conversely, the incorrect classification of T1DM as T2DM causes poor glycaemic control, frequent visits to healthcare services for treatment, inappropriate insulin regimes and risk of Diabetic Ketoacidosis.
Diabetic Ketoacidosis (DKA)
DKA is a potentially life-threatening condition caused by an accumulation of ketones in the body due to insulin deficiency, which is common in patients with T1DM, however, an increasing number of cases have been reported in patients with T2DM. Diagnosis of DKA consists of a high anion gap metabolic acidosis, ketone bodies present in serum and/or urine, and high blood glucose concentration. The symptoms of DKA include:
- Polyuria (excessive urination) and polydipsia (thirst)
- Weight loss
- Dyspnoea (shortness of breath)
- Abdominal pain
- Polyphagia (excess hunger)
- Fruity-smelling breath caused by acetone accumulation.
Randox Type 1 Diabetes Mellitus Genetic Risk Array
T1DM is largely genetic and is associated with over 50 distinct genetic signatures, many of which are single nucleotide polymorphisms (SNPs). This is of great advantage in testing as unlike traditional biomarkers, genetic markers don’t change throughout one’s life, providing a robust method for diagnosis and risk stratification. Genetic data gathered can then be used to develop a genetic risk score, allowing an individual’s probability of developing the disease to be quantified.
Using this principle, together with our patented Biochip array technology, Randox have developed a T1DM GRS array. Using a combination of 10 SNPs from the HLA region and the non-HLA region commonly detected in T1DM patients, and a selection of other risk factors and biomarkers, this molecular array can accurately discriminate between T1DM and T2DM.
Misdiagnosis of DM can have life-threatening consequences. Both types of DM are very common and distinguishing between T1DM and T2DM is crucial.
T1DM is an autoimmune disorder with a lack of insulin secretion, while T2DM is primarily due to insulin resistance. Understanding their mechanisms is vital for accurate diagnosis and treatment. Genetic testing, like the Randox Type 1 Diabetes Mellitus Genetic Risk Array, can differentiate between T1DM and T2DM by analysing genetic markers and providing personalized treatment insights.
Accurate diabetes diagnosis is crucial for proper management, prevention of complications, and improving the lives of millions. Together, we can make a difference in the lives of those affected by diabetes!
If you’d like to learn more about the different types of DM, including the pathogenesis, pathophysiology, associated risk factors, and more, please take a look at our educational guide Diabetes Solutions.
Alternatively, feel free to reach out to our marketing team at firstname.lastname@example.org who will be happy to help you with any queries you may have.
- World Health Organization. Diabetes. World Health Organisation. Published April 5, 2023. Accessed April 25, 2023. https://www.who.int/news-room/fact-sheets/detail/diabetes
- The Misdiagnosis of type 1 and type 2 diabetes in adults. The Lancet Regional Health. 2023;29:100661-100661. doi:https://doi.org/10.1016/j.lanepe.2023.100661
Randox offer over 100 diagnostic reagents covering more than 100 disease markers. Our test panels include cardiology, lipids, specific proteins, therapeutic drug monitoring, antioxidants, diabetes and veterinary diagnostics. Randox reagents are internationally recognised as being of the ‘highest quality’, delivering accurate traceability and precise patient results.
Our methodologies ensure accurate and reliable results compared to traditional methods.
Comprehensive Test Menu
A broad testing panel of 115 diagnostic assays including routine as well as niche reagents unique to Randox
Excellent correlations to gold standard & commercial methods providing confidence in patient results
Applications are available for a range of clinical chemistry analysers offering convenience of use
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Availability of reagents in instrument dedicated bottles, reducing operator time
Versatile test menu enabling laboratories to reduce costs with in-house testing
Randox provide reagents that are applicable for a wide range of testing panels including the below.
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Reagents by instrument
Randox develop and manufacture reagents that can be used on a variety of clinical chemistry analysers. Randox also supply the applications detailing settings for these instruments. All kits are produced to international standard and have ISO 13485 accreditation. See reagents available for the instruments below.
Beckman Coulter AU Systems including DxC700AU
Hitachi 917/Modular P
Mindray BS Series
Roche Cobas 4000 / 6000 / 8000
Thermo Konelab 20i / 30i / 60i
The A-Z Range of Randox Reagents
Select an assay below for more information. Our reagents are suitable for open channels on third party instruments.
ALANINE AMINOTRANSFERASE (ALT)
ANTI-STREPTOLYSIN O (ASO)
ASPARTATE AMINOTRANSFERASE (AST)
CRP FULL RANGE
CRP HIGH SENSITIVITY
Reagent | Lipase
Key Benefits of the Randox Lipase Assay
The Randox lipase assay displayed a precision of <5% CV.
The Randox lipase assay displayed an exceptional correlation coefficient of r=1.00 when compared against other commercially available methods.
Fully automated protocols
Fully automated protocols are available for a variety of clinical chemistry analysers.
Further Benefits of the Randox Lipase Assay
Liquid ready-to-use format for convenience and ease-of-use.
Applications available detailing instrument-specific settings for the convenient use of the Randox lipase assay on a wide range of clinical chemistry analysers.
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
About Lipase Testing
Elevated lipase concentrations 3-to-4-fold greater than the upper normal limit is indicative of pancreatitis, however, the degree of elevations does not correlate with the severity of the disease 2, 3.
In pancreatic dysfunction, lipase concentrations rise between 4 and 6 hours, peaking at 48 hours and returning to baseline within 8 to 14 days. It has a half-life of 6.7 to 13.7 hours in plasma. The half-life of amylase (another assay utilised in the diagnosis of pancreatic dysfunction) is less, however, lipase is filtered by the glomerulus and reabsorbed by the tubules which may contribute towards the longer half-life of lipase.
Lipase offers a few advantages over amylase including: a slightly better specificity, greater sensitivity for patients presenting late, due to the longer half-life, and greater sensitivity in alcoholic pancreatitis 4.
Furthermore, for prolonged longitudinal injuries, lipase activity tends to be more sensitive compared to amylase as lipase concentrations within the zymogen granules are approximately 4.5 times than those of amylase. Consequently, recurring injuries are more likely to be recognised due to the leakage of lipase into the bloodstream. Moreover, lipase concentrations are less affected by intestinal injury or renal dysfunction compared to amylase 2.
Derived from zymogen granules of pancreatic acinar cells, lipase is involved in the digestion of lipids for the subsequent absorption in the small intestine 1, 2. The pancreas is located in the anterior abdominal cavity adjacent to the liver, duodenum and stomach to allow the secretion of digestive enzymes into the small intestine, and to convert ingesta into absorbable lipids, carbohydrates and proteins. The exocrine pancreas provides a microenvironment for pancreatic islet cells. The pancreatic islet cells provide the embedded endocrine function of the pancreas which in turn enables the hepatic and peripheral tissues to modulate blood glucose levels and other functions 2.
Regular cardiovascular disease (CVD) screening is vital to ensure that cardiac risk factors are detected in the earliest stages 1. Early CVD diagnosis aids in reducing the risk of a secondary cardiovascular event through ensuring early intervention and effective treatment plan implementation, thus aiding in the prevention of premature deaths. Early risk assessment is imperative in those with the greatest risk of CVD. This is evaluated through the identification of one or more risk factors including: hypertension, diabetes or hyperlipidaemia 2, 3. It is believed by 2030, almost 23.6 million people will die from CVD, mainly coronary heart disease (CHD) and cerebrovascular disease (CVA), and this is projected to remain the leading causes of death. This provides further confirmation that early diagnosis is vital to prevent and reduce the number of deaths attributed to CVD 3.
Randox offers an extensive range of 21 third party cardiac & lipid testing assays which includes superior performance and unique tests, which are internationally recognised as being of the highest quality; producing accurate and precise results.
Randox offers a range of niche tests including: Adiponectin, H-FABP and sdLDL-C. This means that Randox are one of the only manufacturers to offer these tests in an automated biochemistry format.
Superior Performance Tests
Randox offers numerous cardiac & lipid testing assays that utilise a superior methodology, providing more accurate results. For example, the Randox Lp(a) test is one of the only methodologies on the market that detects the non-variable part of the Lp(a) molecule and therefore suffers from minimal size related bias.
Strong Correlation with Standard Methods
The Randox cardiac & lipid testing assays display strong correlations when compared against standard methods, offering trust and confidence in results.
Wide Measuring Ranges
The Randox cardiac & lipid testing assays can comfortably detect levels outside of the healthy range for the accurate detection of abnormal levels, offering peace of mind in patient samples.
Applications are available detailing instrument-specific settings for the convenient use of the Randox cardiac & lipid testing assays on a wide range of clinical chemistry analysers.
The in vitro diagnostics market is continuously adapting to the changes in laboratory testing. Consequently, Randox have continued to reinvest in R&D to produce a variety of cardiac & lipid testing assays, including superior performance & unique tests, offering laboratories choice, quality and innovation.
The Randox Reagents range of cardiac & lipid testing assays encompasses superior performance & unique tests enabling laboratories to expand their routine test menus without expanding their labs. Not only does Randox Reagents provide confidence in patient results, the outstanding assay development in combination with superior performance methodologies contribute to the uncompromised quality offered by Randox Reagents. Moreover, laboratories can benefit from advanced assay testing with Randox Reagents.
Adiponectin has been identified as having pleiotropic functions widely associated with anti-atherogenic, anti-diabetic, cardioprotective and anti-inflammatory effects. Adiponectin levels inversely correlate with insulin levels, BMI, triglyceride levels, insulin resistance (IR), glucose, and most importantly, visceral fat accumulation 4.
A niche product from Randox, H-FABP is a highly sensitive and early risk marker of acute coronary syndrome, detectable as early as 30 minutes following the onset of an ischaemic episode. The implementation of a combined H-FABP high sensitivity troponin algorithm at an emergency department could aid in the identification of non-AMI patients on arrival, with the potential to reduce hospital admission by 36.8% 5.
Hyperhomocysteinemia can cause inflammation of the endothelium. Failure to lower homocysteine levels can cause further inflammation of the arteries, veins, and capillaries causing atherosclerosis. Women with elevated levels of homocysteine have a 3-fold increased risk of CVD, whereas men have a 2-fold increased risk 6.
A unique product from Randox, Lp(a) has proven to have a causal role in the pathogenesis of atherosclerotic and thrombotic vascular diseases 7. The Randox Lp(a) assay is one of the only methodologies on the market that detects the non-variable part of the Lp(a) molecule and therefore suffers minimal size related bias.
A niche product from Randox, sdLDL-C, a subtype of LDL cholesterol, can more readily permeate the inner arterial wall. Research indicates that individuals with a predominance of sdLDL-C have a 3-fold increased risk of myocardial infarction 8.
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Contact us or download our Cardiology & Lipid Testing brochure to learn more.
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 National Health Service (NHS). Cardiovascular disease. [Online] September 17, 2018. [Cited: November 30, 2018.] https://www.nhs.uk/conditions/cardiovascular-disease/.
 National Institute for Health and Care Excellence (NICE). Cardiovascular disease risk assessment and prevention. [Online] no date. [Cited: November 30, 2018.] https://bnf.nice.org.uk/treatment-summary/cardiovascular-disease-risk-assessment-and-prevention.html.
 World Health Organization (WHO). Cardiovascular diseases (CVDs). [Online] May 17, 2017. [Cited: November 30, 2018.] http://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds).
 New Insight into Adiponectin Role in Obesity and Obesity-Related Diseases. Nigro, Ersilia, et al. Napoli : BioMed Research International, 2014, Vol. 2014.
 Navarro CO, Kurth MJ, Lamont JV, Menown IB, Ruddock MW, Fitzgerald SP et al. Diagnostic Performance of a Combination Biomarker Algorithm for Rule-Out of Acute Myocardial Infarction at Time of Presentation to the Emergency Department, Using Heart-Type Fatty Acid-Binding Protein and High-Sensitivity Troponin T tests. Journal of Clinical & Experimental Cardiology 2018, Vol. 9
 Role of homocysteine in the development of cardiovascular disease. Ganguly, P and Alam, SF. 6, Riyadh, Kingdom : Nutrition Journal, 2015, Vol. 14.
 Lipoprotein(a). von Eckardstein, Arnold. 20, s.l. : European Heart Journal, 2017, Vol. 38.
 Austin. MA, et at, “Low-density lipoprotein subclass patterns and risk of MI”. JAMA 260, 1917, 1988
 Bupa. Coronary Heart Disease. Bupa. [Online] Bupa Health. [Cited: November 30, 2018.] https://www.bupa.co.uk/health-information/heart-blood-circulation/coronary-heart-disease.
 Nall, Rachel. What are the different types of stroke? Healthline. [Online] Healthline, May 24, 2018. [Cited: November 2018, 2018.] https://www.healthline.com/health/stroke-types.
 Mayo Clinic. Mayo Clinic.org. Peripheral artery disease (PAD). [Online] Mayo Clinic. [Cited: November 30, 2018.] https://www.mayoclinic.org/diseases-conditions/peripheral-artery-disease/symptoms-causes/syc-20350557.
Superior Performance & Niche Reagents
Randox offer a range of high performance, unique and niche reagents that are designed to enhance your laboratory testing capabilities.
Our impressive portfolio of high performance & unique tests together with our standard assays sets us apart in the in vitro diagnostics market. Our superior performance reagents and methodologies deliver highly accurate and specific results, that can facilitate earlier diagnosis of disease states with confidence and precision.
Benefits of High Performance Reagents
We can help create cost-savings for your laboratory through excellent stability, eliminating the requirement for costly test re-runs. Our quality reagents also come in a range of different kit sizes to reduce waste and for your convenience.
Confidence in Patient Results
Our traceability of material and extremely tight manufacturing tolerances ensure uniformity across our reagent batches. All of our assays are validated against gold-standard methods.
Applications are available detailing instrument-specific settings for the convenient use of the Randox superior performance & unique assays on a wide variety of clinical chemistry analysers.
Superior Performance Offering
Randox offer an extensive range of 115 assays across routine and niche tests, and cover over 100 disease makers. Our high performance assays deliver superior methodologies, more accurate and specific results compared to traditional methods.
Reduce valuable time spent running tests. Randox reagents come in liquid ready-to-use formats and various kit sizes for convenient easy-fit. Barcode scanning capabilities for seamless programming.
Our range of unique assays means that Randox are one of the only manufacturers to offer these tests in an automated biochemistry format.
The in vitro diagnostics market is continuously adapting to the changes in laboratory testing. Consequently, Randox have continued to reinvest in R&D to produce superior performance & unique tests offering laboratories choice, quality and innovation.
The Randox Lp(a) assay is calibrated in nmol/l and traceable to the WHO/IFCC reference material (IFCC SRM 2B) and provides an acceptable bias compared with the Northwest Lipid Metabolism Diabetes Research Laboratory (NLMDRKL) gold standard. A five-point calibrator with accuracy-based assigned target values (in nmol/l) is available, accurately reflecting the heterogeneity of the apo(a) isoforms.
The Randox bile acids test utilises an advanced enzyme cycling method which displays outstanding sensitivity and precision when compared to traditional enzymatic based tests. The Randox 5th Generation Bile Acids test is particularly useful in paediatrics where traditional bile acids tests are affected by haemolytic and lipaemic samples.
A superior assay from Randox, the vanadate oxidation method offers several advantages over the diazo method, including less interference by haemolysis and lipaemia, which is particularly evident for infant and neonatal populations.
The Randox Fructosamine assay utilises the enzymatic method which offers improved specificity and reliability compared to conventional NBT-based methods. The Randox enzymatic method does not suffer from non-specific interferences unlike other commercially available fructosamine assays.
Soluble transferrin receptor (sTfR) is a marker of iron status. In iron deficiency anaemia, sTfR levels are significantly increased, however remain normal in the anaemia of inflammation. Consequently, sTfR measurement is useful in the differential diagnosis of microcytic anaemia.
During December, we aim to highlight how the Randox product portfolio can be used for accurate diagnosis and monitoring of diabetes, with a focus on the Randox Reagents diabetes panel which offers a total of 12 assays for accurate and reliable diabetes testing.
Diabetes is one of the leading causes of death worldwide and it is estimated by WHO (World Health Organisation) that 2.2 million additional deaths are being caused by the condition each year. The number of people with the condition has being growing rapidly in the last 30 years, the International Diabetes Federation predicts that approximately 438 million people will have diabetes by 2030. Early diagnosis and constant monitoring of diabetes is essential in order to manage the condition, as diabetes can lead to other health problems such as heart disease, kidney damage or failure, nerve damage and even blindness.
Randox knows that this condition cannot be ignored as each year it is increasingly becoming a burden on the health service. Randox Reagents are committed to advancing diabetes related testing and offer an extensive range of high quality reagents: from diabetes diagnosis, to the monitoring of diabetes-related complications, the Randox Reagents diabetes testing panel covers the full spectrum of clinical testing requirements.
Reagents Diabetes Testing Assays
To aid with the growing concern of diabetes, Randox Reagents offer a comprehensive range of 12 assays within their diabetes testing panel including assays for the diagnosis and monitoring of diabetes which includes fructosamine, glucose and HbA1c and also those which monitor diabetes-related complications such as adiponectin, cystatin c, microalbumin and NEFA. The Randox diabetes reagents offer a range liquid ready-to-use and lyophilised formats for increased efficiency, applications are also available for a wide range of biochemistry analysers.
RX series Direct HbA1c Testing Capabilities
Renowned for quality and reliability the RX series range of clinical chemistry analysers boasts a world leading test menu with an extensive range of high performing and unique assays available. In addition to NEFA, D-3-Hydroxybutyrate (Ranbut) and Fructosamine the RX series welcomes Direct HbA1c testing on the RX Daytona +, RX imola and RX modena. The latex enhanced immunoturbidimetric method improves laboratory performance and time, highly improving accuracy and precision by revolutionising your diabetes testing capabilities.
Designed for use in the Quality Control of both HbA1c and Total Haemoglobin assays, our Acusera HbA1c controls are an ideal match for laboratories running these parameters and POCT testing. Available in liquid ready-to-use or lyophilised formats, these controls offer attractive stability and flexibility for labs and healthcare practices of any size. Manufactured using human whole blood which ensures commutability, our controls directly mimic the performance of real patient samples helping deliver reliable results.
RIQAS Glycated Haemoglobin Programme
Designed to monitor the performance of HbA1c, our RIQAS glycated haemoglobin EQA program is suitable for both qualitative and quantitative methods of analysis. As the largest EQA scheme in the world, access to large peer groups is guaranteed. Additional benefits include; monthly analysis, user-friendly reports allowing at-a-glance performance assessment, ability to register up to five instruments per programme and cost savings via our unrivalled consolidation.
More and more women in the United States are waiting until they’re older to start having children.
The number of births to women aged 45–49 rose 14% in 2013 from 2012, according to the Centers for Disease Control and Prevention’s National Vital Statistics Report. With this comes the responsibility by clinicians and laboratories to better assess those at risk of gestational diabetes and to aid better control of the condition for those who already have it. Quick and precise detection of risk of gestational diabetes and associated complications by clinical labs will provide women with the autonomy to take control of their maternal health.
Innovations in maternal health testing have meant that analysis such as adiponectin and enzymatic fructosamine are now available in automated biochemistry formats and with more accurate methodologies; allowing laboratories to assess gestational diabetes risk, and evaluate control of the condition with ease, speed and accuracy. Testing of such analytes have historically been non-routine and not easily accessible for clinical laboratories, and now with little adjustment within the laboratory, these can be added to the test menu allowing for detailed patient testing profiles.
Current innovations in the area of gestational diabetes testing will ultimately secure the health, both during and post-pregnancy, of mother and baby.